Class I recall Z-0152-2027: Philips Ultrasound, LLC
Class I recall Z-0152-2027: Philips Ultrasound, LLC (Washington): Philips Ultrasound, LLC. Dated 7 days ago, it is inside the fresh trigger window. Score 82/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 16 related WA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0152-2027 |
| Recalling firm | Philips Ultrasound, LLC |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Philips Lumify Diagnostic Ultrasound System |
| Reason | Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay. |
| Quantity | 13,206 |
| Distribution | Worldwide - US Nationwide distribution including in the states of CA, MA, IL, NY, OR, GA, TX, WA, FL, PA, WI, LA, NJ, KY, VA, MS, AZ, SC, CT, MN, UT, OH, AL, MI, NH, MO, TN, IN, DC, NE, NM, MT, NV, NC, MD, IA, SD, VT, KS, AK, CO, ID, OK, WV, AR, RI, ME, WY, HI, DE, ND and the countries of CA, NO, HR |
| Recall initiated | 2026-09-24 |
| Reported | 2026-10-28 |
| Firm location | Bothell, WA, United States |
| Peer records CSV (17 WA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class I recall Z-0152-2027: Philips Ultrasound, LLC and 17 Washington peers
- Washington FDAPulse records like this one: 17
- Timing: High: dated in the last 7 days
- Estimated pipeline if you contact every Washington peer: $3,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
82 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 7 days ago.
What is the FDAPulse record for Class I recall Z-0152-2027: Philips Ultrasound, LLC in Washington?
Class I device recall Z-0152-2027 by Philips Ultrasound, LLC: Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with
How does Class I recall Z-0152-2027: Philips Ultrasound, LLC compare to other Washington FDAPulse records?
It is fresh: dated 7 days ago, inside the window where early outreach matters most. Its Predicate Speed & CAPA Advisory Opportunity Score of 82/100 puts it among the stronger signals in this feed.
Class I recall Z-0152-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class I recall Z-0152-2027 | WA | 2026-10-28 |
| Class I recall Z-0127-2027 | WA | 2026-10-28 |
| Class I recall Z-0132-2027 | WA | 2026-10-28 |
| Class I recall Z-0131-2027 | WA | 2026-10-28 |
Compare Class I recall Z-0152-2027 vs Class I recall Z-0122-2027 →
Compare Class I recall Z-0152-2027 vs Class I recall Z-0123-2027 →
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